Barisione E.

Bassetti M.

Blasi F.

Bruzzi P.

Castaldo N.

Centanni S.

Corcione S.

De Rosa F. G.

Di Marco F.

Giacobbe D. R.

Gori A.

Gramegna A.

Granata G.

Gratarola A.

Lombardi A.

Maraolo A. E.

Mikulska M.

Pea F.

Petrosillo N.

Radovanovic D.

Santus P.

Signori A.

Sozio E.

Tagliabue E.

Tascini C.

Vancheri C.

Vena A.

Viale P.

English

Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

LETTERA Response to: Letter to the Editor RegardingManagement of Adult Patients with COVID-19 OutsideIntensive Care Units: Guidelines from the ItalianSociety of Anti-Infective Therapy (SITA)and the Italian Society of Pulmonology (SIP)Matteo Bassetti . Daniele Roberto Giacobbe . Paolo Bruzzi . Emanuela Barisione . Stefano Centanni .Nadia Castaldo . Silvia Corcione . Francesco Giuseppe De Rosa . Fabiano Di Marco . Andrea Gori .Andrea Gramegna . Guido Granata . Angelo Gratarola . Alberto Enrico Maraolo . Malgorzata Mikulska .Andrea Lombardi . Federico Pea . Nicola Petrosillo . Dejan Radovanovic . Pierachille Santus . Alessio Signori .Emanuela Sozio . Elena Tagliabue . Carlo Tascini . Carlo Vancheri . Antonio Vena . Pierluigi Viale .Francesco Blasi on behalf of the Italian Society of Anti-infective Therapy (SITA), the Italian Society ofPulmonology (SIP)Received: October 15, 2021 / Accepted: November 9, 2021 / Published online: December 10, 2021 The Author(s) 2021Keywords: COVID-19; mAbs; Monoclonalantibodies; SARS-CoV-2; Casirivimab;Imdevimab; GuidelinesDear Editor,We thank Manciulli and colleagues for theircomment on the recently released guidelinesfrom the Italian Society of Anti-InfectiveM. Bassetti (&)  D. R. Giacobbe (&) M. Mikulska  A. VenaInfectious Diseases Unit, Ospedale Policlinico SanMartino, IRCCS, L.go R. Benzi, 10, 16132 Genoa,Italye-mail: matteo.bassetti@unige.itD. R. Giacobbee-mail: danieleroberto.giacobbe@unige.itM. Bassetti  D. R. Giacobbe  M. MikulskaDepartment of Health Sciences (DISSAL), Universityof Genoa, Genoa, ItalyP. BruzziClinical Epidemiology Unit, Ospedale PoliclinicoSan Martino, IRCCS, Genoa, ItalyE. Barisione  E. TagliabueInterventional Pulmonology, Ospedale PoliclinicoSan Martino, IRCCS, Genoa, ItalyS. CentanniRespiratory Unit, ASST Santi Paolo e Carlo, Milan,and Department of Health Sciences, Università degliStudi di Milano, Milan, ItalyN. Castaldo  E. Sozio  C. TasciniInfectious Diseases Clinic, Santa Maria MisericordiaHospital, Udine, ItalyS. Corcione  F. G. De RosaDepartment of Medical Sciences, InfectiousDiseases, University of Turin, Turin, ItalyS. CorcioneTufts University School of Medicine, Boston, MA,USAF. Di MarcoRespiratory Unit, Department of Health Sciences,ASST Papa Giovanni XXIII Hospital, University ofMilan, Bergamo, ItalyA. Gori  A. LombardiInfectious Diseases Unit, Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico, Milan, ItalyA. Gori  A. Gramegna  A. Lombardi  F. BlasiDepartment of Pathophysiology andTransplantation, Università degli Studi di Milano,Milan, ItalyInfect Dis Ther (2022) 11:635–638https://doi.org/10.1007/s40121-021-00564-xTherapy (SITA) and the Italian Society of Pul-monology (SIP) on the clinical management ofadult patients with coronavirus disease 2019(COVID-19) outside intensive care units [1, 2].In their comment, Manciulli and colleagueshighlight that, while in the guidelines there is arecommendation against the use of neutralizingmonoclonal antibodies in inpatients withCOVID-19 (pending results of ongoing trials),the Italian Medicine Agency (AIFA) has recentlyallowed the use of casirivimab/imdevimab athigh dosage in hospitalized seronegativepatients with COVID-19 [3]. This apparent dis-crepancy is mostly related to the fact that therandomized trial (currently available as a non-peer-reviewed pre-print manuscript [4]) sup-porting the AIFA decision became available onlyvery recently, after the last literature updatedictating guidelines development. The possi-bility of novel evidence becoming availableafter the release of the guidelines was not un-expected. Indeed, a novel rigorous literaturesearch supporting a predefined update of thecurrent guidelines is about to start in November2021, as stated in the guideline methods [1].Nonetheless, it is certainly true that novelevidence cannot be ignored. For this reason,pending the predefined update of the currentguidelines, we invite Italian physicians to fol-low the most recent regulatory document, i.e.,the current AIFA recommendations on the useof neutralizing monoclonal antibodies in non-hospitalized and hospitalized patients withCOVID-19. However, an important point ofcaution is that neither the certainty of evidencenor the strength for this recommendation canbe reliably defined without the propermethodology. Indeed, the formulation of thefinal, updated SITA and SIP recommendationson the use of neutralizing monoclonal anti-bodies (both in inpatients and in outpatientsand both for intravenous and for other availableformulations) will be provided after followingthe same rigorous systematic steps that weretaken during the preparation of the first releaseddocument. This is necessary to guarantee theA. GoriCentre for Multidisciplinary Research in HealthScience (MACH), University of Milan, Milan, ItalyA. Gramegna  F. BlasiInternal Medicine Department, Respiratory Unitand Cystic Fibrosis Adult Center, Fondazione IRCCSCa’ Granda Ospedale Maggiore Policlinico, Milan,ItalyG. GranataClinical and Research Department for InfectiousDiseases, National Institute for Infectious Diseases L.Spallanzani, IRCCS, Rome, ItalyA. GratarolaDepartment of Emergency and Urgency, SanMartino Policlinico Hospital, IRCCS, Genoa, ItalyA. E. MaraoloFirst Division of Infectious Diseases, CotugnoHospital, AORN dei Colli, Naples, ItalyF. Pea  P. VialeDepartment of Medical and Surgical Sciences, AlmaMater Studiorum-University of Bologna, Bologna,ItalyF. PeaSSD Clinical Pharmacology Unit, UniversityHospital, IRCCS Azienda Ospedaliero UniversitariaDi Bologna, Bologna, ItalyN. PetrosilloInfection Control and Infectious Disease Service,University Hospital ‘‘Campus-Biomedico’’, Rome,ItalyD. Radovanovic  P. SantusDivision of Respiratory Diseases, Ospedale L. Sacco,ASST Fatebenefratelli-Sacco, Milan, ItalyP. SantusDepartment of Biomedical and Clinical Sciences(DIBIC), Università degli Studi di Milano, Milan,ItalyA. SignoriSection of Biostatistics, Department of HealthSciences, University of Genoa, Genoa, ItalyC. VancheriRegional Referral Centre for Rare Lung Diseases-University Hospital ‘‘Policlinico G. Rodolico’’,Catania, ItalyC. VancheriDepartment of Clinical and Experimental Medicine,University of Catania, Catania, ItalyP. VialeInfectious Diseases Unit, University Hospital IRCCSPoliclinico Sant’Orsola, Bologna, Italy636 Infect Dis Ther (2022) 11:635–638required high-quality standards for guidelinedevelopment.ACKNOWLEDGEMENTSFunding. No funding or sponsorship wasreceived for this study or publication of thisarticle.Authorship. All named authors meet theInternational Committee of Medical JournalEditors (ICMJE) criteria for authorship for thisarticle, take responsibility for the integrity ofthe work as a whole, and have given theirapproval for this version to be published.Author Contributions. Matteo Bassetti:project chair for SITA, project concept, votingpanel member, revision of final manuscript andsupplementary material. Francesco Blasi: pro-ject chair for SIP, project concept, voting panelmember, revision of final manuscript and sup-plementary material. Daniele Roberto Gia-cobbe: project coordinator, methodology andsystematic reviews, assessment of evidence withthe GRADE system, drafting of recommenda-tions, drafting of final manuscript and supple-mentary material, supervision of voting process.Pierluigi Viale, Malgorzata Mikulska, NicolaPetrosillo, Andrea Gori, Carlo Tascini, FrancescoGiuseppe De Rosa, Pierachille Santus, FabianoDi Marco, Stefano Centanni, Carlo Vancheri,Angelo Gratarola, Federico Pea: voting panelmembers, revision of final manuscript andsupplementary material. Antonio Vena, GuidoGranata, Silvia Corcione, Emanuela Sozio,Nadia Castaldo, Andrea Lombardi, Andrea Gra-megna, Dejan Radovanovic, Elena Tagliabue:search strings development, conduction of sys-tematic reviews, drafting of recommendations,revision of final manuscript and supplementarymaterial. Alessio Signori: development andsupervision of methodology together with theproject coordinator, revision of final manuscriptand supplementary material. Alberto EnricoMaraolo: development and supervision ofmethodology together with the project coordi-nator, assessment of evidence with the GRADEsystem, search strings development, revision offinal manuscript and supplementary material.Paolo Bruzzi: development and supervision ofmethodology together with the project coordi-nator, assessment of evidence with the GRADEsystem, revision of final manuscript and sup-plementary material.List of Investigators. Matteo Bassetti,Daniele Roberto Giacobbe, Paolo Bruzzi, Ema-nuela Barisione, Stefano Centanni, Nadia Cas-taldo, Silvia Corcione, Francesco Giuseppe DeRosa, Fabiano Di Marco, Andrea Gori, AndreaGramegna, Guido Granata, Angelo Gratarola,Alberto Enrico Maraolo, Malgorzata Mikulska,Andrea Lombardi, Federico Pea, Nicola Pet-rosillo, Dejan Radovanovic, Pierachille Santus,Alessio Signori, Emanuela Sozio, Elena Tagli-abue, Carlo Tascini, Carlo Vancheri, AntonioVena, Pierluigi Viale, Francesco Blasi.Disclosure. Outside the submitted work,Daniele Roberto Giacobbe reports an uncondi-tional grant from Correvio Italia and a grant forhis institution by Pfizer Inc. Outside the sub-mitted work, Matteo Bassetti has receivedfunding for scientific advisory boards, traveland speaker honoraria from Angelini, Astellas,Bayer, BioMérieux, Cidara, Cipla, Gilead,Menarini, MSD, Pfizer, Shionogi, Tetraphase,Nabriva. Outside the submitted work, FrancescoBlasi reports grants and personal fees fromAstraZeneca, grants from Bayer, grants andpersonal fees from Chiesi, grants and personalfees from GlaxoSmithKline, personal fees fromGrifols, personal fees from Guidotti, personalfees from Insmed, grants and personal fees fromMenarini, personal fees from Novartis, grantsand personal fees from Pfizer, personal fees fromZambon, and personal fees from Vertex. Out-side the submitted work, Emanuela Barisionereports personal fees from Boehringer Ingel-heim, personal fees from Chiesi, and personalfees from GlaxoSmithKline. Outside the sub-mitted work, Federico Pea participated inspeaker bureau for Angelini, Basilea Pharma-ceutica, Gilead, Hikma, Merck Sharp & Dohme,Nordic Pharma, Pfzer and Sanofi Aventis, and inadvisory board for Angelini, Basilea Pharma-ceutica, Correvio, Gilead, Hikma, Merck SharpInfect Dis Ther (2022) 11:635–638 637& Dohme, Nordic Pharma, Novartis, Pfizer,Shionogi and Thermo-Fisher. Outside the sub-mitted work, Nicola Petrosillo reports personalfees from MSD, personal fees from Pfizer, per-sonal fees from Johnson & Johnson, personalfees from Shionogi, personal fees from Takeda,and personal fees from Becton & Dickinson.Outside the submitted work, Pierachille Santusreports personal fees from Gilead. Paolo Bruzzi,Stefano Centanni, Nadia Castaldo, Silvia Cor-cione, Francesco Giuseppe De Rosa, Fabiano DiMarco, Andrea Gori, Andrea Gramegna, GuidoGranata, Angelo Gratarola, Alberto Enrico Mar-aolo, Malgorzata Mikulska, Andrea Lombardi,Dejan Radovanovic, Alessio Signori, EmanuelaSozio, Elena Tagliabue, Carlo Tascini, CarloVancheri, Antonio Vena, and Pierluigi Vialehave nothing to disclose.Compliance with Ethics Guidelines. Thisarticle is based on previously conducted studiesand does not contain any new studies withhuman participants or animals performed byany of the authors.Open Access. This article is licensed under aCreative Commons Attribution-NonCommer-cial 4.0 International License, which permitsany non-commercial use, sharing, adaptation,distribution and reproduction in any mediumor format, as long as you give appropriate creditto the original author(s) and the source, providea link to the Creative Commons licence, andindicate if changes were made. The images orother third party material in this article areincluded in the article’s Creative Commonslicence, unless indicated otherwise in a creditline to the material. If material is not includedin the article’s Creative Commons licence andyour intended use is not permitted by statutoryregulation or exceeds the permitted use, youwill need to obtain permission directly from thecopyright holder. To view a copy of this licence,visit http://creativecommons.org/licenses/by-nc/4.0/.REFERENCES1. Bassetti M, Giacobbe DR, Bruzzi P, et al. Clinicalmanagement of adult patients with COVID-19 out-side intensive care units: guidelines from the ItalianSociety of Anti-Infective Therapy (SITA) and theItalian Society of Pulmonology (SIP). Infect Dis Ther.2021;10(4):1837–85.2. Manciulli T, Spinicci M, Bartoloni A, et al. Mono-clonal antibodies for hospitalized patients withCOVID-19 in Italy. Infect Dis Ther. 2021.3. AIFA. DETERMINA 4 agosto 2021. https://www.aifa.gov.it/documents/20142/847786/GU_187_06_08_2021_casirivimab-imdevimab.pdf. Accessed 15 Oct2021.4. RECOVERY Collaborative Group, Horby PW, MafhamM, et al. Casirivimab and imdevimab in patientsadmitted to hospital with COVID-19 (RECOVERY): arandomised, controlled, open-label, platform trial.medRxiv. 2021:2021.06.15.21258542. https://doi.org/10.1101/2021.06.15.21258542.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdic-tional claims in published maps and institutionalaffiliations.638 Infect Dis Ther (2022) 11:635–638

A Response to: Letter to the Editor Regarding Management of Adult Patients with COVID-19 Outside Intensive Care Units: Guidelines from the Italian Society of Anti-Infective Therapy (SITA) and the Italian Society of Pulmonology (SIP)

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A Response to: Letter to the Editor Regarding Management of Adult Patients with COVID-19 Outside Intensive Care Units: Guidelines from the Italian Society of Anti-Infective Therapy (SITA) and the Italian Society of Pulmonology (SIP)

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